Participates in inspection readiness activities and significantly involved in inspections by regulatory agencies.
September 12, 2022
Performs test verification studies in accordance with NYSDOH submission packets, validations and writes procedure manuals and training checklists.
October 01, 2022
Demonstrates strong interpersonal and communication skills (both written and oral), a strong customer focus, and an ability to interact with various departments and levels.
February 10, 2023
Manages completion of entire method validation/verification including the coordination of approvals for protocols/report, completion of experiments by other junior analysts, incorporation of comments into protocols/report, and overall completion to agreed timelines and ensuring communication/escalation of potential issues of broader impact to the business.
February 21, 2023
Meets all requirements of federal and state regulations for an MLT with good organizational and communication skills.
March 04, 2023
Develop proposals and plans for major client management, and project plan the launch of new devices through the regulatory process.
March 16, 2023
Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
March 18, 2023
Assists manufacturing area managers or designates with areas identified for trouble-shooting, for corrective actions related to quality investigations.
March 19, 2023
Works closely with other ISS, marketing, and management to adopt a system sell approach into large Pharmaceutical and Personal care accounts working with bench personnel to senior managers.
April 17, 2023
Support testing for raw materials, drug substance and drug product, including generation of testing data to support clinical studies.
May 01, 2023